WASHINGTON – The Food and Drug Administration (FDA) has announced that its ongoing safety review of the abortion pill, mifepristone, will extend into next year. This decision has sparked immediate backlash from anti-abortion advocates who are eager to see the drug’s use limited.
In a recent court-ordered filing, the FDA provided an update on its progress regarding this controversial reevaluation, which was mandated by Health Secretary Robert F. Kennedy Jr. Mifepristone has been a focal point in the ongoing national debate surrounding abortion access since its approval by the FDA in 2000.
Over the years, the FDA has consistently confirmed the safety and effectiveness of mifepristone, even relaxing certain restrictions, such as the requirement for in-person dispensing. However, with the return of President Donald Trump to the White House, there has been renewed pressure from anti-abortion groups and their congressional allies to reassess the drug’s status.
According to the FDA’s filing, the agency is expected to complete its safety study by mid-December of this year, with a report on its findings due by March 2027. This timeline raises concerns as it could lead to potential new restrictions or changes in how mifepristone is administered.
Critics of the FDA’s timeline, such as Gavin Oxley from Americans United for Life, argue that the administration is failing to prioritize women’s health. Oxley stated, “The administration continues to find itself on the wrong side of women’s health, clearly uninterested in mitigating the ongoing harms caused by the abortion pill.”
Mifepristone, when combined with the drug misoprostol, constitutes the most common method of abortion in the United States. The FDA’s update comes as part of a legal case initiated by Louisiana, which argues that the mail delivery of mifepristone undermines the state’s abortion ban. This case is part of a series of similar lawsuits concerning mifepristone that are currently navigating through the judicial system.
In a recent development, a three-judge panel for the 5th U.S. Circuit Court of Appeals scrutinized the validity of Louisiana’s claims, questioning whether the state has the legal standing to challenge the FDA’s oversight of mifepristone. It’s important to note that any ruling from the 5th Circuit would not immediately alter the current landscape, as the Supreme Court has temporarily blocked any changes to the drug’s status until it reassesses the case.
The FDA is employing a “statistical data mining method” to uncover any potential unknown safety concerns associated with mifepristone. This data is derived from an electronic database that aggregates reports of medical injuries and drug-related side effects from major health providers and insurers.
In addition to the ongoing safety study, the FDA is also reviewing several petitions that propose changes to the prescription and distribution processes for mifepristone. One of the main points of contention for abortion opponents has been the 2021 decision that allows doctors to prescribe mifepristone online and send it via mail—a decision that was made permanent under President Joe Biden in 2023. This shift has effectively undermined several state-level abortion restrictions, as women can now receive the medication without needing to visit a clinic in person.
As the situation continues to evolve, the implications of the FDA’s safety review and the ongoing legal battles will play a significant role in shaping the future of abortion access in the United States.
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